Evaluation and performance characteristics of the Q Hemostasis Analyzer, an automated coagulation analyzer

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• 作者：Pierre Toulon^a ; ^b ; ^{toulon.p@chu-nice.fr" class="auth_mail} ; Florence Fischer^b ; Anny Appert-Flory^b ; Didier Jambou^b
• 关键词：aPTT ; activated partial thromboplastin time ; AT ; antithrombin ; CV ; coefficient of variation ; FV ; (coagulation) factor V ; FVIII ; (coagulation) factor VIII ; INR ; international normalized ratio ; ISI ; international sensitivity index ; MNPT ; mean normal prothrombin time ; OD ; optical density ; PC ; protein C ; PT ; prothrombin time ; QC ; quality control ; SD ; standard deviation ; TT ; thrombin time ; UFH ; unfractionated heparin ; vWF ; Ag ; von Willebrand factor antigen
• 刊名：Thrombosis Research
• 出版年：May, 2014
• 年：2014
• 卷：133
• 期：5
• 页码：927-935
• 全文大小：357 K

文摘

The Q Hemostasis Analyzer (Grifols, Barcelona, Spain) is a fully-automated random-access multiparameter analyzer, designed to perform coagulation, chromogenic and immunologic assays. It is equipped with a cap-piercing system. The instrument was evaluated in a hemostasis laboratory of a University Hospital with respect to its technical features in the determination of coagulation i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin time, fibrinogen and single coagulation factors V (FV) and VIII (FVIII), chromogenic [antithrombin (AT) and protein C activity] and immunologic assays [von Willebrand factor antigen (vWF:Ag) concentration], using reagents from the analyzer manufacturer. Total precision (evaluated as the coefficient of variation) was below 6% for most parameters both in normal and in pathological ranges, except for FV, FVIII, AT and vWF:Ag both in the normal and pathological samples. No carryover was detected in alternating aPTT measurement in a pool of normal plasma samples and in the same pool spiked with unfractionated heparin (> 1.5 IU/mL). The effective throughput was 154 PT, 66 PT/aPTT, 42 PT/aPTT/fibrinogen, and 38 PT/aPTT/AT per hour, leading to 154 to 114 tests performed per hour, depending of the tested panel. Test results obtained on the Q Hemostasis Analyzer were well correlated with those obtained on the ACL TOP analyzer (Instrumentation Laboratory), with r between 0.862 and 0.989. In conclusion, routine coagulation testing can be performed on the Q Hemostasis Analyzer with satisfactory precision and the same apply to more specialized and specific tests.